OTS Hip
Not disclosed publicly
Regulatory Status Disclosed
Overview
OTS Hip by Ortoma AB is an AI-assisted orthopedic surgical platform designed to support total hip arthroplasty (THA). The system integrates preoperative 3D planning, intraoperative navigation, and postoperative verification into a unified clinical workflow. It is developed for orthopedic surgeons and surgical teams operating in hospital and clinical settings.
The platform consists of two primary software modules that integrate into the standard surgical workflow:
- OTS Hip Plan (OHP): A server-based 3D planning tool that processes patient CT scan data. Using automated AI algorithms, the software performs bone segmentation, identifies anatomical landmarks, and suggests optimal implant sizes and positioning within minutes. Surgeons can then review, fine-tune, and validate the plan.
- OTS Hip Guide (OHG): An intraoperative navigation system that transfers the validated preoperative plan directly to the operating room. It utilizes a passive marker sensor system and a tracked freehand probe to provide real-time tracking of surgical tools, assisting the surgeon in precisely placing the implant relative to the patient’s anatomy.
The system is designed with a small physical footprint to integrate into existing operating room setups with minimal disruption to conventional surgical techniques.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-powered surgical planning
- 3D preoperative planning based on CT imaging data
- Intraoperative navigation and guidance for implant placement
- Postoperative verification and follow-up
- Optimizes patient outcomes, precision, and efficiency
- Reduces complications and need for follow-up surgeries
- Suggests suitable implant type and size
- Automatic AI analysis for planning (approx. 30 seconds)
- Integrates into existing surgical workflows
- Server-based integrated AI platform
Use Cases
- Preoperative planning for Total Hip Arthroplasty (THA)
- Intraoperative guidance during hip replacement surgery
- Optimizing implant positioning in hip surgery
- Reducing surgical time and improving efficiency in THA
- Post-operative analysis of hip implant placement
- Patient-specific planning for joint replacement
What Physicians Need to Know
Surgical Planning Capabilities
Utilizes AI-based algorithms for anatomical landmark detection, bone segmentation, 3D representation, and implant size/type/placement suggestion. It provides a precise optimal position for implant components and suggests prosthesis type and size from the hospital's implant database. The system offers CT-based 3D planning and can generate an automatic AI analysis for pre-operative planning, including implant suggestions and optimized positioning, within approximately 30 seconds. It also includes simulation of range of motion and delivers CT scan data for planning within 4 minutes, significantly reducing traditional waiting times.
Intraoperative Guidance
Functions as an intraoperative guidance system for total hip replacement procedures, aiding in surgical precision and shortening operation duration. It provides real-time guidance for surgeon-controlled conventional tools and prosthesis component placement relative to the pre-operatively planned position and patient anatomy. An IR-based camera and reflective markers on tracers display cup orientation and position on a screen to assist optimal placement. The Hip Guide module offers notable precision in cup placement, reducing the risk of mispositioning outside the patient-specific safe zone.
3D Reconstruction Quality
Employs AI-based algorithms for bone segmentation and 3D representation. The CT-based 3D planning generates clinically accurate 3D models of the hip joint for surgical preparation. Segmentation accuracy has been demonstrated as excellent, even in cases of severe hip dysplasia.
Surgical Navigation Accuracy
Achieves high precision in cup placement, with mean errors in patient surgeries reported as -0.07 u00b1 2.72u00b0 for anteversion, -0.2 u00b1 0.86u00b0 for inclination, and 0.28 u00b1 0.78 mm for cup depth. Studies show 100% implant size accuracy within a margin of u00b11 size, with exact matches for cup and head implant sizes in over 96.8% of cases and for stem implants in over 90.3% of cases. The accuracy is influenced by factors such as camera tracking data, instrument calibration, CT imaging quality, bone segmentation, 3D bone reconstruction, and patient alignment algorithms. Computer-assisted navigation is associated with reduced variability in implant positioning, decreased postoperative dislocation, and a lower risk of aseptic loosening.
Pre-Operative Assessment
Leverages CT imaging for comprehensive preoperative planning. It uses AI to detect anatomical landmarks, segment bones, create 3D representations, and suggest optimal implant size, type, and placement. The system rapidly processes CT scan data, providing results within 4 minutes for efficient planning. It also includes the capability to simulate range of motion.
Post-Operative Monitoring
Includes a dedicated 'Follow-up' module. This module utilizes AI-based CT-RSA for migration analysis, relying on automatically generated bone and implant segmentation and anatomical landmarks from integrated machine learning models, eliminating the need for tantalum markers. Post-operative CT scans are typically performed within a week after surgery, and then at 3 months, 1 year, and 2 years postoperatively for ongoing migration analysis.
Operating Room Workflow Integration
Designed for easy integration into existing surgical processes and routines, which enhances efficiency. Surgeons can use their own equipment with only minor modifications, facilitating a comfortable transition to the technology. The system's small footprint contributes to an easier workflow with minimal deviation from established surgical techniques. Optimized workflows and new accessories also help reduce preparation time for surgery.
Physician Tip
Leverage OTS Hip for highly precise, AI-assisted pre-operative planning to optimize implant selection and positioning, which can be completed rapidly from CT scan data. Utilize the real-time intraoperative guidance to ensure accurate implant placement, potentially reducing surgical time and improving patient outcomes. The system's ability to integrate with existing surgical tools and its small footprint make it a comfortable addition to the operating room workflow.
The OTS Hip system is designed for seamless integration with current surgical practices and existing conventional surgical instruments, requiring only minor alterations. It is a modular platform, with components like Hip Plan, Hip Guide, and Follow-up, and is compatible with various implant components, such as those from DePuy Synthes.
Details
| Category | Surgical AI |
| Pricing | Not disclosed publicly — Contact vendor for details |
| Deployment | Server-based integrated AI platform, used at the point of care, designed for immediate integration into hospital systems. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated The OTS Hip system received 510(k) clearance (K250086) from the U.S. Food and Drug Administration (FDA) on March 11, 2024. It is indicated for planning orthopedic surgical procedures based on CT medical imaging data and for intraoperative image-guided localization during total hip arthroplasty (THA). |
| Integrations | |
| EHR | Not specified |
| Specialties | Orthopedics |
What the Web Says
Ortoma's OTS Hip is an AI-assisted surgical system for total hip arthroplasty (THA) that has received 510(k) clearance from the FDA, allowing it to be marketed in the United States. The system aims to improve surgical precision, efficiency, and patient outcomes by enabling surgeons to accurately plan 3D surgery and optimally position implants during the procedure. It includes OTS Hip Plan for preoperative planning and OTS Hip Guide for intraoperative real-time navigation.
Overall: PositiveStrengths
- Enhances precision and accuracy in implant positioning.
- Aids in preoperative planning with 3D analysis based on CT imaging.
- Provides intraoperative real-time navigation for surgical tools and prosthetic components.
- Potentially leads to better patient outcomes, fewer complications, and reduced reoperations.
- Can be easily integrated into existing surgical workflows.
- Offers faster CT scan data processing (within 4 minutes) for planning.
Limitations
- Limited long-term outcome data currently available for newer robotic systems in THA.
- Robotic-assisted THA may require longer operative times compared to manual techniques.
- Increased cost and hospital charges associated with robotic and navigated THA.
- Potential difficulties in determining the proper native femoral center of rotation in dysplastic hips.
- Some studies suggest no significant difference in functional outcomes or dislocation rates compared to manual techniques.
- Dependency on engineers for some robotic systems.
Based on reviews from: accessdata.fda.gov, ODT Magazine, Orthopedic Reviews, SICOT-J, PMC, Northwell Health, OrthoFeed, MedWorld Advisors, Reddit
Last updated: 2026-07-18
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Press & Coverage
BioStock
Ortoma u2013 Nyckelhu00e4ndelser och finansiell utveckling under Q1 2024
This article from BioStock discusses Ortoma's key events and financial development during Q1 2024, likely touching upon their OTS Hip system in the context of company performance and strategic outlook.
2024-05
Ortoma Press Release
Ortoma receives order for OTS Hip from new clinic in Sweden
Ortoma announced receiving an order for its OTS Hip system from a new clinic in Sweden, indicating continued market penetration and adoption of their technology.
2024-04
Cision / Ortoma AB
Ortoma receives order for OTS Hip from new clinic in Sweden
This Cision press release reiterates Ortoma's announcement of a new order for the OTS Hip system from a Swedish clinic, highlighting ongoing commercial progress.
2024-04
Avanza / Placera
Ortoma receives order for OTS Hip from new clinic in Sweden
Avanza's Placera section published Ortoma's press release regarding a new order for OTS Hip from a clinic in Sweden, signaling positive business development.
2024-04
BioStock
Ortoma u2013 Framsteg med OTS Hip och marknadsutveckling
BioStock covers Ortoma's progress with the OTS Hip system and broader market development, likely discussing clinical adoption and strategic initiatives.
2024-03
Ortoma AB
Ortoma AB (publ) - u00c5rsredovisning 2023
Ortoma's 2023 Annual Report provides a comprehensive overview of the company's financial performance and strategic developments, including updates on the OTS Hip system's progress and market activities.
2024-03
Ortoma AB
Ortoma AB (publ) - Delu00e5rsrapport Q4 2023
Ortoma's Q4 2023 interim report details the company's financial results and operational highlights for the quarter, likely including updates on the commercialization and clinical use of OTS Hip.
2024-02
Ortoma AB
Ortoma AB (publ) - Kommuniku00e9 fru00e5n u00e5rsstu00e4mma 2023
This communiquu00e9 from Ortoma's 2023 Annual General Meeting outlines key decisions and discussions, which may include strategic directions impacting the OTS Hip system's development and market strategy.
2023-05
Videos
Product demos, reviews, and walkthroughs for OTS Hip.
Trading Direkt Healthcare 2023-05-29 | Artificiella hju00e4rtan, Ortomas nya produkt och Diamyd Medical
Direkt Studios
Frequently Asked Questions
The OTS Hip system integrates by providing both preoperative planning and intraoperative guidance. It utilizes medical imaging data, such as CT scans, to create a 3D environment for surgeons to plan implant size and position, and then offers real-time navigation during surgery to guide instruments and prosthetic components according to the plan.
The OTS Hip system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), allowing it to be marketed in the United States. It is classified as a Class II stereotaxic instrument and must comply with FDA regulations including Quality System (QS) regulation (21 CFR Part 820), labeling, and medical device reporting.
Alternatives include traditional manual surgical planning and execution, as well as other computer-assisted or robotic-arm assisted technologies like Mako. Non-surgical alternatives for hip pain management include lifestyle modifications, physical therapy, medications, and injections, while other surgical alternatives to total hip replacement include hip arthroscopy, hip resurfacing, and partial hip replacement.
While specific pricing for OTS Hip is not publicly detailed, AI-assisted technologies in hip replacement can add to the overall cost of the procedure, which typically ranges from $18,175 to $74,000 in the US, depending on various factors. Some insurance plans may not cover the robotic or AI-assisted portion of the surgery, leading to higher out-of-pocket expenses for patients.
While AI aims to enhance precision, limitations can include the reliance on high-quality imaging data, the need for intraoperative navigation validation, and potential unsuitability for patients with severe osteoporosis. General limitations of total hip replacement, regardless of AI assistance, include restricted range of motion, lifelong precautions to avoid dislocation, and the finite lifespan of implants.
AI in systems like OTS Hip is designed to improve accuracy in assessing acetabular component position and leg length discrepancy during total hip arthroplasty. It provides automated patient-specific functional pelvic tracking and real-time image interpretation with smart grid overlays, aiding surgeons in achieving precise osteotomy and optimal implant placement.
Physicians must ensure that AI platforms like OTS Hip comply with strict data security and privacy regulations, such as HIPAA in the US, given that the system processes sensitive patient medical imaging data in DICOM format. Safeguarding this data from breaches and ensuring its ethical use are paramount concerns.
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| Last Verified: 2026-04-18 | First Added: 2026-04-18